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Completed

NCT Number: NCT02160457

Gait Analysis and Interdisciplinary Interventions for Children With Cerebral Palsy

The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by instrumented 3-dimensional gait analysis are superior to those used in 'care as usual'.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark - Odense University Hospital

Odense, Denmark

About this study

Children with cerebral palsy (CP) who walk independently often have an altered gait pattern. Interdisciplinary interventions in terms of orthopaedic surgery, spasticity management, physical therapy and orthotics aim to improve the gait pattern. Standardised measurements are used in the Cerebral Palsy follow-Up Program to assess walking. However, these measurements do not describe features in the gait pattern reflecting underlying neuro-musculoskeletal impairments. This can be done with instrumented 3-dimensional gait analysis (IGA). It has never been investigated whether interdisciplinary interventions designed to address impairments identified by IGA result in improved gait pattern compared with 'care as usual' without IGA in children with CP. The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by IGA are superior to those used in 'care as usual'.

A prospective, single blind, randomised, parallel group study will be conducted. Participants will be recruited from the Cerebral Palsy follow-Up Program. Children aged 5 to 9 years with spastic CP, classified at Gross Motor Function Classification System levels I or II will be included. The interventions under investigation are 1) Individually tailored interdisciplinary intervention addressing impairments identified by IGA and 2) 'care as usual' (interdisciplinary interventions without IGA). The primary outcome is gait pattern measured by the Gait Deviation Index. Secondary outcome measures are, walking performance and patient-reported outcomes of functional mobility, health-related quality of life and overall health, pain and participation. Explorative outcome measures include walking performance, gait pattern, behavior of health care providers and the applied interventions. The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks after start of intervention; however, exclusively for the patient-reported outcomes.

To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention designed to address impairments identified by IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA in interdisciplinary interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spastic Cerebral palsy
  • Gross Motor Function Classification System levels I or II.

Exclusion criteria

  • Earlier interventions in the form of orthopaedic surgery within the past 52 weeks, injection with botulinum toxin type A in the 12 weeks prior to baseline assessments
  • Relocation to another region during the trial.
  • If the child not are able to demonstrate sufficient co-operation and cognitive understanding to participate in the IGA.

Treatment and study plan

Intervention with IGA

Other

Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis

The instrumented gait analysis consists of four steps:

  • Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000)
  • Impairment-Focused Interpretation
  • Recommendation for interdisciplinary interventions
  • Dissemination of recommendations

The two modalities differs in the use of IGA, but the study is not indented to document the effect of IGA alone, but to document the difference in the effects of the interdisciplinary interventions, when IGA is implemented to the experimental group.

Other names: Vicon T40 system, Vicon, Oxford, UK, Advanced Mechanical Technology Inc. (AMTI), OR6-7-1000, Watertown, USA

Primary outcomes

  1. Change from baseline in Gait Deviation Index

    Time frame: Baseline, 52 weeks

    Gait Deviation Index (GDI) is based upon kinematic data from the Instrumented Gait Analysis, and is an quantitative index that summarises the overall gait pattern into a single score for each patient by comparison with non-pathological gait. A GDI value of 100 represents the absence of gait pathology, and each 10-point decrement below 100 indicates one standard deviation from normal gait kinematics. For the primary outcome measure, the median of five trials for each leg will be used to calculate the average of both legs to provide a single index for each child.

Secondary outcomes

  1. Change from baseline in 1-minute walk test

    Time frame: Baseline, 52 weeks

    Walking performance is assessed with the 1-minute walk test. The test measure the distance in meters, when the child walks as fast as possible.

  2. Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory

    Time frame: Baseline, 52 weeks

    The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions.

  3. Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module

    Time frame: Baseline, 52 weeks

    The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning.

  4. Change from baseline in Pediatric Outcome Data Collection Instrument

    Time frame: Baseline, 52 weeks

    The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities.

  5. Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory

    Time frame: Baseline, 26 weeks

    The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions.

  6. Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module

    Time frame: Baseline, 26 weeks

    The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning.

  7. Change from baseline in Pediatric Outcome Data Collection Instrument

    Time frame: Baseline, 26 weeks

    The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities.

Other outcomes

  1. Change from baseline in Gait Variable Score

    Time frame: Baseline, 52 weeks

    The Gait Variable Score is used to measure changes in gait pattern. Gait Variable Score is an index for a single gait variable. The Gait Variable Scores are determined for the following nine variables: Pelvic tilt, pelvic obliquity, pelvic rotation, hip flexion, hip adduction, hip rotation, knee flexion, dorsiflexion and foot progression

  2. Change from baseline in Measure of Processes of Care

    Time frame: Baseline, 52 weeks

    Measure of Processes of Care is a self-report measure of parents' perception of the extent to which the health services that their child receives are family-centred.

  3. Applied interventions

    Time frame: 52 weeks

    Records from the Cerebral Palsy Follow-Up Program of the applied interventions will be used to explore differences (used vs. not used) in the use of the following intervention categories in the two groups: Orthopaedic surgery, Spasticity management, Physical Therapy and Orthotics.

  4. Difference in recommended and applied interventions

    Time frame: Baseline, 52 weeks

    Records from the Cerebral Palsy Follow-Up Program of the recommended and actually applied interventions in the experimental group will be used to explore the differences (used vs. not used) in the recommended and actually applied interventions in regard to the following categories: Orthopaedic surgery, Spasticity management, Physical Therapy and Orthotics.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Association of Danish Physiotherapists
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Ludvig and Sara Elsass Foundation
  • Odense University Hospital
  • Region of Southern Denmark
  • Sonderborg Hospital
  • Sygehus Lillebaelt
  • University of Salford

Registry information

Official study title

Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial

Acronym: CPinMotion

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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